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ICH Public Meeting January 21, 2003 5630 Fishers Lane, Room 1066

ICH Public Meeting January 21, 2003 5630 Fishers Lane, Room 1066. The Clinical Evaluation of QT Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. Justina A. Molzon, M.S. Pharm., J.D. Associate Director for International Programs

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ICH Public Meeting January 21, 2003 5630 Fishers Lane, Room 1066

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  1. ICH Public Meeting January 21, 2003 5630 Fishers Lane, Room 1066 The Clinical Evaluation of QT Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Justina A. Molzon, M.S. Pharm., J.D. Associate Director for International Programs Center for Drug Evaluation and Research/USFDA CDER ICH Steering Committee Representative

  2. ICH S7B • Safety Pharmacology Studies for Assessing the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) By Human Pharmaceuticals • Released for consultation under Step 2 of the ICH process in February 2002. • Consultation (Step 3):FDA: Published in the Federal Register on June 14, 2002, vol. 67, n.115, Friday, p. 40950-40951

  3. Clinical Evaluation of QT Interval ProlongationBackground • Document drafted by Canada’s Therapeutic Products Directorate • CDER working on a similar document • Recognized value of a joint effort • Value of a harmonized ICH document • However recognized the need for expertise outside the ICH process

  4. ICH Streamlined ProcedureProposed • Jump starts ICH process by using a draft or final document in one of the ICH regions (including observers) that would provide a strong foundation for the development of the ICH guideline • Ensures the inclusion of the necessary experts outside the ICH process

  5. Workshop Designed to Discuss Document January 13-14, 2003 • Preliminary Concept Paper • Posted on DIA, ICH, TPD, CDER, website November 20, 2002 • Invited experts outside the ICH process for scientific discussion • NASPE (North American Society of Pacing and Electrophysiology) • ICH Working Group present for the discussion

  6. New Paradigm • Different approach for all of us • Outside norm for guideline development, ICH, CDER, TPD • Different venue and process for DIA • Academic setting to promote academic discussions • More than twice the normal number of panelists for a program • One of the largest programs outside the annual meeting with 620 attendees

  7. Workshop Efforts---->ICH • Transcript to capture discussion • Resulting recommendations and conclusions will be incorporated into the document for ICH consideration • ICH QT prolongation Working Group to continue working on document at Tokyo meetings, February 3-6, 2002 • RESULT=Harmonized approach

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